Lean Six Sigma can help medical device companies do a better job at identifying and putting corrective and preventive actions (CAPA) into place. That could provide a big step forward for the industry as companies frequently do not put proper procedures in place to guide the development of CAPAs.

This lack of procedures, as well as “inadequate causal analysis, lack of data integrity, and ineffective controls to prevent nonconformances,” is one of the reasons why CAPAs often end up being the result of warning letters from the Food and Drug Administration, according to a medical device industry expert writing for Med Device Online.

Putting Lean Six Sigma into action “can turbocharge the CAPA process,” wrote Rai Chowdhary, CEO of the consulting firm KPI System.

The Four Stages of CAPA

A CAPA in the medical device industry is meant to create a system for addressing systematic quality issues. A CAPA is triggered by the company itself when it finds a quality issue, or by a warning from the FDA when the federal agency becomes aware of nonconformities (in other words, something that doesn’t meet regulatory standards).

In either case, the goal of a CAPA is to find the root cause of a problem and then come up with a solution. As every Lean Six Sigma practitioner knows, this is exactly the type of situation where Lean excels.

CAPAs typically happen in four stages.

  • Containment And Correction: This is when companies take fast steps to control the damage and stop the spread of nonconformities. Time is not taken at this point to find root causes.
  • Causal Analysis And Corrective Action: Finding the root causes of the nonconformities and finding solutions.
  • Identifying Potential Nonconformances And Preventive Actions: After corrective actions are in place, companies then look at what else can go wrong to prevent further conformance issues.
  • Verification Of Effectiveness: Designing ways to measure whether the solution has worked.

In addressing nonconforming issues, medical device companies can keep in mind the overall goal of Six Sigma, which is to create processes that only experience 3.4 defects for every one million chances. That translates into a 99.99966% success rate. Businesses can calculate their own baseline sigma to find out where things now stand before making improvements.

Saving $250,000 and Permanently Fixing an Issue

Chowdhary provides an example of Lean in action with a medical device company. A medical implant manufacturer started producing parts that had a mild straw color rather than the expected white. By using Lean in the four areas above, they not only moved much faster to find the root cause of the problem but also to develop a solution.

For example, in the first stage they used Lean visual management techniques to separate out the wrong-colored batchers. Later, they used fishbone diagrams to identify variables that could cause the discoloration and process mapping to sequence the process steps.

Eventually, it was discovered a number of variables caused the issue, including thermal mass in the oven used to heat parts for the implant and the temperature at which the oven door was opened to remove parts. By using Failure Modes and Effects Analysis, the company also anticipated other issues, such as air leaks in the oven, and addressed them before they could cause problems in the process.

The company saved $250,000 and a year after using Lean for the CAPA process, they still had zero defects.

As pointed out in Med-Tech News, medical device manufacturers can take lessons from the Toyota Production System to improve how they address initial manufacturing of devices, as well. This includes the concepts of Kaizen, or making small improvements continuously to improve an operation.

They noted that medical device manufacturers work in a fast-paced environment where the focus on innovation “can sometimes push out of view other ways of improving profitability.” Using Lean Six Sigma, these companies can become more efficient at CAPAs and overall process improvement, improving both product quality and the bottom line.